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A federal appeals court in Washington upheld patents issued to Myriad Genetics on isolated gene sequences used to diagnose breast cancer, rejecting a challenge from the American Civil Liberties Union and others who said genes shouldn’t be able to be patented. The 2:1 decision by the U.S. Court of Appeals for the Federal Circuit also might set up yet another fight between the highest court of appeal for patents and the U.S. Supreme Court, which forced the Federal Circuit to reconsider Myriad after reversing the lower court on another landmark case this year.

The case pitted Salt Lake City-based Myriad against researchers and critics who said Myriad’s patented on the BRCA genes found in breast tumors hindered research into the deadly disease. Myriad lawyers have sent threatening letters to the University of Pennsylvania and others, urging researchers isolating those genes to desist or pay royalties. The ACLU joined with the Association for Molecular Pathology and other groups in urging the court to declare such purified snippets of DNA as unpatentable.

“This ruling prevents doctors and scientists from exchanging their ideas and research freely,” said said Chris Hansen, a staff attorney with the ACLU Speech, Privacy and Technology Project. “Human DNA is a natural entity like air or water. It does not belong to any one company.”

The majority’s decision also drew a strong dissent from Judge William Bryson, who said it “if sustained, will likely have broad consequences, such as preempting methods for whole-genome sequencing.”

Judge Alan Lourie dismissed such criticism as irrelevant, saying the court was only restating what has been the law for decades.

“It is important to state what this appeal is not about,” Lourie wrote. It isn’t about “whether is it desirable for one company to hold a patent or license covering a test that may save people’s lives, or for other companies to be excluded from the market encompassed by such a patent. Those questions are not before us.”

The only questions before the court were whether isolated gene sequences are eligible to be patented, he said, and the answer is yes. The very act of isolating sequences of molecules from the much larger DNA molecule transforms them into something useful, the judge said, just like any other industrial process based on naturally occurring compounds. The refining industry has thousands of patents on processes that revolve around extracting naturally occurring hydrocarbon molecules, for example; it’s the difficulty of creating hydrocarbons any other way that makes crude oil so valuable.

The court did reject two elements of the patents, one of which it had previously upheld. The act of comparing a patient’s isolated gene material with a reference sample is an abstract mental exercise, the court held, rather than a patentable process. This was a nod to this year’s Mayo v. Prometheus decision, where it reversed the Federal Circuit to hold that a process based on observing changes in a metabolite in a patient’s body was not patentable.

Prometheus doesn’t address the patentability of isolated DNA, however, so Myriad’s victory could be short-lived if the plaintiffs appeal.

“There’s still a great deal of uncertainty because the Supreme Court has not had the final word on this issue,” said Antoinette Konski, an intellectual property lawyer with Foley and Lardner in Palo Alto, Calif. “And that’s disappointing to the industry.”

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< "an isolated gene is different in form from any naturally occurring material and therefore it is patent eligible…"

This is an outrage. We are flirting with a dangerous future when we say that a company can patent human DNA. How can the rationale be that human DNA is "different in form" – when the BRCA gene occurs naturally? Can we say next that we'll allow a company to patent isolated genes that contribute to common traits like blue eyes and brown hair?